Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF… recallZ-2038-2023 · Remel, Inc · initiated May 31, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Remel, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The test medium may not perform as intended.
FDA root cause category: Under Investigation by firm
What the company is doing
The firm issued recall letters dated 5/31/2023 via mail on 5/31/2023 that were flagged as URGENT: Deliver to Micro Lab. The letter provides the reason for the field action, risk to health, the product and distribution information, and actions to be taken by the customer. The actions included the consignee review reported results by an appropriate technical expert. The letter should be passed onto all who need to be aware within the consignee's organization or to any organization where the affected products have been transferred. An Acknowledgement Form was enclosed for return to the firm via email. The form is for the consignee to acknowledge receipt of the recall notice and that it is understood, and the information and required actions have been brought to the attention of all relevant users and executed. The deadline for returning the form is 6/30/2023.
Recall details
- Recall number
- Z-2038-2023
- Status
- Open, Classified
- Initiated by the company
- May 31, 2023
- Posted by the FDA
- Jun 29, 2023
- Recalling firm
- Remel, Inc
- Quantity
- 1,296 packs
- Product code
- JSO
- FDA submissions
- K892928
- Distribution
- Distribution was made nationwide, including Puerto Rico. There was no foreign or military distribution.
Product description
Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use.
Code information (models, lots, serial numbers)
REF R04033 lot numbers and expiration dates: Lot 619859 Exp. 2023-03-23, Lot 629086 Exp. 2023-03-31, Lot 629087 Exp. 2023-03-31, Lot 631001 Exp. 2023-04-11, Lot 634496 Exp. 2023-04-18, Lot 635369 Exp. 2023-04-19, Lot 645950 Exp. 2023-05-11, Lot 648004 Exp. 2023-05-18, and Lot 651372 Exp. 2023-05-23. UDI-DI #00848838004476. REF R01503 lot numbers and expiration dates: Lot 623548 Exp. 2023-03-28, Lot 631958 Exp. 2023-04-12, Lot 641527 Exp. 2023-05-02, Lot 644542 Exp. 2023-05-09, and Lot 648125 Exp. 2023-05-16. UDI-DI #00848838001932.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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